TCR² Therapeutics Announces Clinical Trial Collaboration Agreement with Bristol Myers Squibb to Evaluate Gavo-cel in Combination with Opdivo® and Yervoy® in Mesothelin-Expressing Solid Tumors
October 25 2021 - 6:45AM
TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell
therapy company with a pipeline of novel T cell therapies for
patients suffering from solid tumors, today announced a clinical
trial collaboration agreement with Bristol Myers Squibb (NYSE: BMY)
to evaluate gavo-cel in combination with Opdivo® (nivolumab) and
Yervoy® (ipilimumab) in its planned Phase 2 clinical trial in
treatment refractory mesothelin-expressing solid tumors. The
primary objective of the Phase 2 trial is to evaluate the efficacy
of gavo-cel in patients with unresectable, metastatic or recurrent
mesothelin-expressing cancers including non-small cell lung cancer
(NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma
(MPM) and cholangiocarcinoma. TCR2 is sponsoring the Phase 2 trial.
“We are very pleased to establish a
collaboration agreement with Bristol Myers Squibb for our Phase 2
clinical trial as this enables us to evaluate the potential synergy
between gavo-cel and immune checkpoint inhibitors,” said Garry
Menzel, Ph.D., President and Chief Executive Officer of TCR2
Therapeutics. “The new standard of care established by Opdivo in
difficult-to-treat diseases is important for cancer patients around
the world, including the recent approval of the combination of
Opdivo and Yervoy as first-line treatment for adult patients with
unresectable malignant pleural mesothelioma. We look forward to
determining whether gavo-cel can provide additional clinical
benefit to these patients.”
The planned Phase 2 clinical trial will evaluate
the antitumor activity and better characterize the safety of
gavo-cel at the selected recommended Phase 2 dose (RP2D). Patients
will receive gavo-cel at the RP2D and will be enrolled according to
their cancer diagnosis to four distinct cohorts: NSCLC, ovarian
cancer, MPM and cholangiocarcinoma. Patients with NSCLC, ovarian
cancer, or cholangiocarcinoma will receive the combination of
gavo-cel and Opdivo. Patients with MPM will be treated in three
cohorts: the first will administer gavo-cel as a single agent, the
second will treat patients with both gavo-cel and Opdivo, and the
third will treat patients with gavo-cel, Opdivo and Yervoy.
Opdivo® and Yervoy® are trademarks of
Bristol-Myers Squibb Company.
About
TCR2
Therapeutics
TCR2 Therapeutics Inc. is a
clinical-stage cell therapy company developing a pipeline of novel
T cell therapies for patients suffering from solid
tumors. The company is focused on the discovery and
development of product candidates against novel and complex targets
utilizing its proprietary T cell receptor (TCR) Fusion
Construct T cells (TRuC®-T cells). The TRuC platform is
designed to specifically recognize and kill cancer cells by
harnessing signaling from the entire TCR, independent of human
leukocyte antigens (HLA). For more information about TCR2, please
visit www.tcr2.com.
Forward-looking
Statements
This press release contains forward-looking
statements and information within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws. The use of words such as "may," "will," "could",
"should," "expects," "intends," "plans," "anticipates," "believes,"
"estimates," "predicts," "projects," "seeks," "endeavor,"
"potential," "continue" or the negative of such words or other
similar expressions can be used to identify forward-looking
statements. These forward-looking statements include, but are not
limited to, express or implied statements regarding the therapeutic
potential of gavo-cel, timing for interim updates for the gavo-cel
and TC-110 clinical trials, expectations regarding manufacturing
plans and capabilities, future clinical development and
commercialization plans, the development of the Company’s TRuC-T
cells, their potential characteristics, applications and clinical
utility, and the potential therapeutic applications of the
Company’s TRuC-T cell platform.
The expressed or implied forward-looking
statements included in this press release are only predictions and
are subject to a number of risks, uncertainties and assumptions,
including, without limitation: uncertainties inherent in clinical
studies and in the availability and timing of data from ongoing
clinical studies; whether interim results from a clinical trial
will be predictive of the final results of the trial; whether
results from preclinical studies or earlier clinical studies will
be predictive of the results of future trials; the expected timing
of submissions for regulatory approval or review by governmental
authorities, including review under accelerated approval processes;
orphan drug designation eligibility; regulatory approvals to
conduct trials or to market products; TCR2’s ability to maintain
sufficient manufacturing capabilities to support its research,
development and commercialization efforts, including TCR2’s ability
to secure additional manufacturing facilities; whether TCR2's cash
resources will be sufficient to fund TCR2's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements, the impact of the COVID- 19 pandemic on TCR2’s
ongoing operations; and other risks set forth under the caption
"Risk Factors" in TCR2’s most recent Annual Report on Form 10-K,
most recent Quarterly Report on Form 10-Q and its other filings
with the Securities and Exchange Commission. In light of these
risks, uncertainties and assumptions, the forward-looking events
and circumstances discussed in this press release may not occur and
actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements. You
should not rely upon forward- looking statements as predictions of
future events. Although TCR2 believes that the expectations
reflected in the forward-looking statements are reasonable, it
cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur.
Moreover, except as required by law, neither
TCR2 nor any other person assumes responsibility for the accuracy
and completeness of the forward-looking statements included in this
press release. Any forward-looking statement included in this press
release speaks only as of the date on which it was made. We
undertake no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
Investor and
Media Contact:Carl MauchDirector,
Investor Relations and Corporate Communications (617)
949-5667carl.mauch@tcr2.com
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